FDA Adverse Event
Malfunction
Summary report: N
LINET
MDR report key: 16627159
·
Received March 28, 2023
Report
- Report Number
- 16627159
- Event Type
- Malfunction
- Date Received
- March 28, 2023
- Date of Event
- March 15, 2023
- Report Date
- March 21, 2023
- Manufacturer
- LINET AMERICAS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A NURSE WAS REMOVING SEIZURE PADS FROM A BED SIDE RAIL AND THE CLEAR PLASTIC PORTION OF THE PAD BROKE. SHE STATED WAS USING PROPER TECHNIQUE TO REMOVE THE PAD AND THE PLASTIC SUDDENLY BROKE WHEN SHE PULLED ON IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13863 | LINET | BED, AC-POWERED, ADJUSTABLE, HOSPITAL | FNL | LINET AMERICAS | MCHDLF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |